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Research and Development of Key Technologies and Systems for Assessment, Early Warning, and Multi-Physical Factor Collaborative Stimulation Intervention in Elderly Consciousness/Cognitive Impairment—A Randomized, Controlled Clinical Study on Temporal Interference Deep Brain Stimulation for Disorders of Consciousness

Research and Development of Key Technologies and Systems for Assessment, Early Warning, and Multi-Physical Factor Collaborative Stimulation Intervention in Elderly Consciousness/Cognitive Impairment—A Randomized, Controlled Clinical Study on Temporal Interference Deep Brain Stimulation for Disorders of Consciousness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102973
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-05-23
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders of consciousness

Interventions

Thalamic group:Left thalamic temporal interference stimulation
Sham stimulus group:None

Sponsors

The Third Affiliated Hospital of Sun Yat sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-70 years old; (2) Duration of disease>=4 weeks; (3) impairment of consciousness (e.g., trauma, stroke, ischemic-hypoxic encephalopathy, etc.); (4) Patients diagnosed with unresponsive arousal syndrome (UWS) or microconscious state (MCS) using CRS-R; (5) Vital signs are stable and can complete the research trial; (6) If you use awareness-improving drugs, at least 2 weeks or more, the dose will not be adjusted during the enrollment period; (7) The patient's family members voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Consciousness impairment caused by neurodegenerative diseases, brain tumors and other causes; (2) Combined epilepsy (seizures within 1 month before enrollment); (3) Metal or electronic device implants (e.g., pacemakers, cochlear implants, deep brain stimulators, spinal cord stimulation, aneurysm clips, internal fixation devices after ventriculoperitoneal shunts, etc.); (4) EEG, MRI and PET-CT are contraindicated, and the examination cannot be completed; (5) Other serious diseases that may affect the study.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale - Revised Score;

Secondary

MeasureTime frame
Improvement rate;Glass Coma Scale Score;Glasgow Outcome Score;Resting electroencephalogram;Functional magnetic resonance imaging;

Countries

China

Contacts

Public ContactXiquan Hu

The Third Affiliated Hospital of Sun Yat sen University

1973376262@qq.com+86 189 2210 2910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026